Clexane multidose vial - Patient Information Leaflet (PIL) (2023)

• Keep this leaflet. You may have to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medication is prescribed just for you. Do not give it to others. You can harm them even if the signs of the disease are the same as yours.
• If you notice any side effects, talk to your doctor or pharmacist. This includes possible side effects that are not listed in this instruction. See section 4.

1. What Clexane Multidose Vial is and what it is used for
2. What you need to know before you start using the Clexane multidose vial
3. How to use the Clexane multidose vial
4. Possible side effects
5. Storage of the Clexane multidose vial
6. Package content and other information

The Clexane multidose vial works in two ways:

1) Prevent existing blood clots from growing. This helps your body break them down and prevents them from harming you.

2) Prevent the formation of new blood clots in the blood.

The Clexane multidose vial can be used for:

• Treat blood clots in the blood
• Prevent the formation of blood clots in the blood in the following situations:
  • before and after surgery
  • when you have a short-term illness and cannot move for a while
  • if you have had a blood clot due to cancer to prevent the formation of new clots
• Avoid blood clots if you have unstable angina (where too little blood reaches the heart) or after a heart attack
• Prevent blood clots from forming in the tubing of your dialysis machine (used for people with severe kidney problems).

• you are allergic to:
  • enoxaparin sodium or any other ingredient of this medicine (listed in section 6).
  • heparin or other "low molecular weight heparins" such as nadroparin, tinzaparin, or dalteparin.
  Signs of an allergic reaction include: rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes.
• have had a reaction to heparin that caused a severe drop in the number of clotting cells (platelets) in the past 100 days
• you have antibodies to enoxaparin in your blood
• are bleeding a lot or have a condition with a high risk of bleeding, such as:
  • a stomach ulcer, recent brain or eye surgery, or a recent stroke.
• use a multi-dose vial of Clexane to treat blood clots and within 24 hours you will experience:
  • spinal or lumbar puncture
  • surgery with epidural or spinal anesthesia.
• the patient is a premature infant or newborn up to 1 month of age due to the risk of serious toxicity including abnormal respiration ("wheezing syndrome").

Do not use the Clexane multidose vial if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before you start taking the multidose vial of Clexane.

The Clexane multidose vial must not be mixed with other "low molecular weight heparins" such as nadroparin, tinzaparin or dalteparin. This is because they are not exactly the same and do not have the same action and instructions for use.

Talk to your doctor or pharmacist before using the Clexane multidose vial if:

• have ever had a reaction to heparin that caused a severe drop in the number of clotting cells (platelets)
• had a heart valve implanted
• have endocarditis (infection of the inner lining of the heart)
• you have a history of stomach ulcer
• you recently had a stroke
• Do you have high blood pressure
• have diabetes or problems with the blood vessels in the eye caused by diabetes (called diabetic retinopathy)
• you have recently had eye or brain surgery
• you are an elderly person (over 65), especially if you are over 75
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• have high levels of potassium in your blood (this can be checked with a blood test)
• are currently taking medicines that affect bleeding (see section 2, 'Other medicines and the multidose vial of Clexane')
• you have back problems or have had back surgery.

If any of the above apply to you (or if you are not sure), talk to your doctor or pharmacist before you start taking the multidose vial of Clexane.

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (called "metabolic acidosis").

For patients receiving doses greater than 210 mg/day, this medication contains more than 24 mg sodium (the main ingredient in table salt) in each dose.

This is equivalent to 1.2% of the maximum recommended daily intake of sodium for an adult.

Before you start using this medicine and at intervals while you are using it, you may have a blood test; this is to check the level of clotting cells (platelets) and potassium in the blood.

The safety and efficacy of Clexane multidose vials in children or adolescents have not been evaluated.

Tell your doctor or pharmacist if you are taking or might take any other medicines.

• warfarin – used to thin the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots (see section 3, “Changing anticoagulants”)
• dextran injection – used as a blood substitute
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory drugs used to treat pain and swelling in arthritis and other conditions
• prednisolone, dexamethasone, or other medicines used to treat asthma, rheumatoid arthritis, and other conditions
• medicines that increase the level of potassium in the blood, such as potassium salts, diuretics and some medicines for heart problems.

If you are going to have a spinal or lumbar puncture or surgery under epidural or spinal anaesthesia, tell your doctor that you are using the multidose vial of Clexane.

If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before using this medicine.

If you are pregnant and have a mechanical heart valve, you may be at increased risk of developing blood clots. Your doctor should discuss this with you.

If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking this medicine.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build up in your body and cause side effects (called "metabolic acidosis").

Clexane Vial Multidose does not affect the ability to drive vehicles and machines.

• The Clexane multidose vial formulation contains benzyl alcohol (15 mg/ml). This is a preservative. It can cause toxic and allergic reactions in children up to 3 years of age. It should not be used in babies who are premature or less than 1 month old due to the risk of serious toxicity, including abnormal respiration.
• It is recommended to use the formulation of Clexane Multidose Vial without benzyl alcohol in pregnant women.

It is recommended that your healthcare professional write down the trade name and batch number of the product you are using.

• Your doctor or nurse will normally give you a multidose vial of Clexane. This is because it must be given as an injection.
• The Clexane multi-dose vial is usually given by injection under the skin (subcutaneously).
• The Clexane multidose vial can be given by injection into a vein (intravenously) after certain types of heart attack or surgery.
• The Clexane multidose vial can be added to a tube that leaves the body (arterial line) at the start of dialysis.
• Do not inject the Clexane multidose vial into a muscle.

• Your doctor will decide how many multidose vials of Clexane to give you. The amount will depend on what it is used for.
• If you have kidney problems, you may be given a smaller amount from the multidose vial of Clexane.

1) Treat blood clots in the blood

• The usual dose is 150 IU (1.5mg) for every kilogram of body weight once a day or 100 IU (1mg) for every kilogram of body weight twice a day.
• Your doctor will decide how long you should receive the multidose vial of Clexane.

2) Stop the formation of blood clots in the blood during operations or periods of limited mobility due to illness

• The dose will depend on how likely you are to develop a clot. You will receive multi-dose vials of Clexane of 2,000 IU (20 mg) or 4,000 IU (40 mg) per day.
• If you are going to have surgery, you will usually receive your first injection 2 to 12 hours before surgery.
• If you have limited movement due to illness, you will normally receive 4000 IU (40mg) multidose vials of Clexane per day.
• Your doctor will decide how long you should receive the multidose vial of Clexane.

3) Stop blood clots when you have unstable angina or after a heart attack

• The Clexane multidose vial can be used for two different types of myocardial infarction.
• The amount of the Clexane multidose vial you receive will depend on your age and the type of heart attack you have had.

Type of heart attack NSTEMI (non-ST-segment elevation myocardial infarction):

• The usual dose is 100 IU (1 mg) for each kilogram of body weight every 12 hours.
• Your doctor will usually ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive the multidose vial of Clexane.

Type of heart attack STEMI (ST-segment elevation myocardial infarction) if you are under age 75:

• You will be given a starting dose of 3000 IU (30mg) multidose vials of Clexane as an injection into a vein.
• At the same time, you will also receive a multi-dose vial of Clexane as an injection under the skin (subcutaneous injection). The usual dose is 100 IU (1 mg) for each kilogram of body weight every 12 hours.
• Your doctor will usually ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive the multidose vial of Clexane.

A type of STEMI heart attack if you are 75 or older:

• The usual dose is 75 IU (0.75 mg) for each kilogram of body weight every 12 hours.
• The maximum amount of the Clexane multidose vial administered in the first two injections is 7500 IU (75 mg).
• Your doctor will decide how long you should receive the multidose vial of Clexane.

For patients undergoing a procedure called percutaneous coronary intervention (PCI):

• Depending on when you last received a multidose vial of Clexane, your doctor may decide to administer an additional dose of a multidose vial of Clexane before PCI surgery. This is by injection into a vein.

4) Avoid blood clots in the tubing of your dialysis machine

• The usual dose is 100 IU (1 mg) for every kilogram of body weight.
• The Clexane multi-dose vial is added to a tube that leaves the body (arterial line) at the start of a dialysis session.
• This amount is usually enough for a 4 hour session. However, your doctor may give you an additional dose of 50 IU to 100 IU (0.5 to 1 mg) for every kilogram of your body weight, if necessary.

If you can give yourself the multidose vial of Clexane, your doctor or nurse will show you how. Do not try to give yourself an injection if you have not been trained to do so. If you are not sure what to do, talk to your doctor or nurse right away. Correctly administering the injection under the skin (called a "subcutaneous injection") will help reduce pain and bruising at the injection site.

• Gather the necessary items: a multidose vial of Clexane, a syringe, an alcohol swab or soap and water, and a sharps container
• Check the expiration date of the medication. Do not use if the date has passed
• Check that the bottle is not damaged and that the medicine it contains is a clear solution. If not, use another bottle.
• Make sure you know how much to inject.
• Check your abdomen to see if the last injection caused any redness, skin discoloration, swelling, discharge, or still pain. If so, contact your doctor or nurse.
• The Clexane multi-dose vial should be injected just under the skin in the stomach, but not too close to the belly button or any scar tissue (at least 2 inches away). Decide where to inject the medicine. Each time, change the injection site from the right side of the stomach to the left side.

Preparation of the injection site.

1) Select the area on the right or left side of the abdomen. It should be at least 5 inches away from your belly button and to the side.

• Do not inject closer than 5 cm from the navel or around existing scars or bruises.
• Change the injection site between the left and right sides of the abdomen, depending on where you last injected.

2) Wash your hands. Clean (do not rub) the area to be injected with a cotton ball dipped in alcohol or soap and water.

3) Sit or lie down in a comfortable position to stay relaxed. Make sure you can see where you are going to give the injection. A chaise lounge, recliner or bed with pillows are ideal.

injection

1) Withdraw the correct dose from the vial with the appropriate syringe. A drop may appear at the tip of the needle. If this happens, remove the drop before injection by tapping the syringe with the needle pointing down. You are now ready to inject.

2) Hold the syringe in the hand you are writing with (like a pen). With the other hand, gently squeeze the clean part of the abdomen between your index finger and thumb to create a fold in the skin.

• Be sure to support the skin fold during the injection.

3) Hold the syringe with the needle pointing down (90° vertically). Insert the needle all the way into the skin fold.

4) Press the plunger with your thumb. This will send the medicine into the fatty tissue in your stomach. Complete the injection using all of the medicine in the syringe.

5) Remove the needle from the injection site by pulling it out. Keep the needle away from yourself and other people. You can now drop the skin fold.

When you finish

1) To avoid bruising, do not rub the injection site after self-injection.

2) Place the used syringe in the sharps container. Close the lid of the container tightly and place it out of the reach of children. When the container is full, discard it as directed by your doctor or pharmacist.

Any unused or waste medicine should be disposed of in accordance with local regulations.

• Switching from multi-dose vials of Clexane to blood thinners called vitamin K antagonists (such as warfarin)
  The doctor will ask you for some blood tests called INR and will tell you when to stop taking the Clexane Multidose bottle.
• Switching from blood thinners called vitamin K antagonists (such as warfarin) to a multidose vial of Clexane
  Stop taking the vitamin K antagonist. Your doctor will ask you to have a blood test called the INR and will tell you when to start taking Clexane Multidose Vial.
• Change from Clexane multidose vial to direct treatment with oral anticoagulants
  Stop taking the multidose vial of Clexane. Start taking the direct oral anticoagulant 0 to 2 hours before your next injection is due and continue as usual.
• Change of treatment from direct oral anticoagulants to a multidose vial of Clexane
  Stop taking a direct oral anticoagulant. Do not start treatment with multidose vials of Clexane within 12 hours of the last dose of direct oral anticoagulant.

If you think you have used too much or too little of the Clexane multidose vial, tell your doctor, pharmacist or nurse immediately, even if you have no signs of a problem. If a child accidentally injects or swallows a multidose vial of Clexane, take him to a hospital emergency room right away.

If you forget to take a dose, take it as soon as you remember. Do not take a double dose on the same day to make up for a forgotten dose.

Keeping a diary will help you not miss a dose.

It is important that you continue to receive Clexane multidose injections in the vial until your doctor decides to stop them. If it stops, you could have a blood clot which could be very dangerous.

Stop using the Clexane multidose vial and talk to your doctor or nurse right away.if you have any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat or eyes).

Stop using the Clexane multidose vial and seek immediate medical attention if you experience any of the following symptoms:

• A red, scaly rash with bumps under the skin and blisters accompanied by a fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Like other similar anticoagulant medicines, Clexane Multidose Vial can cause bleeding. This can be deadly. In some cases, the bleeding may not be visible.

• have any bleeding that does not stop on its own
• you have signs of excessive bleeding, such as feeling very weak, tired, pale or dizzy with a headache or unexplained swelling

Your doctor may decide to monitor you more closely or change your medication.

• if you have any signs of a blood vessel being blocked by a blood clot, such as:
  • cramping, redness, warmth or swelling of one of the legs: these are symptoms of deep vein thrombosis
  • shortness of breath, chest pain, fainting, or coughing up blood: these are symptoms of a pulmonary embolism
• if you have a painful rash with dark red spots under your skin that do not go away when you press on them

Your doctor may ask you to have a blood test to check your platelet count.

Very often(may occur in more than 1 in 10 people):

• bleeding
• increased liver enzymes

Habitual(you can be contacted by a maximum of 1 in 10 people):

• you bruise more easily than normal; this may be due to a blood problem with low platelets
• pink patches on the skin – these are more likely to appear in the area where the multidose vial of Clexane was injected
• skin rash (hives, hives)
• itchy red skin
• bruising or pain at the injection site
• decrease in the number of red blood cells
• high blood platelet count
• headache

Unusual(up to 1 in 100 people may apply):

• sudden severe headache – this could be a sign of bleeding in the brain
• feeling of tenderness and swelling in the stomach - you may have bleeding in the stomach
• large red irregularly shaped lesions on the skin with or without blisters
• skin irritation (local irritation)
• yellow skin or eyes and dark urine – this could be a problem with the liver

cru(may occur in up to 1 in 1,000 people):

• severe allergic reaction - signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• increased potassium in the blood: this is more likely to happen in people with kidney problems or diabetes. Your doctor will be able to check this with a blood test.
• increased number of eosinophils in the blood; your doctor can check this with a blood test
• Hair loss
• osteoporosis (a condition in which bones are more likely to break) after long-term use
• tingling, numbness, and muscle weakness (especially in the lower body) when you had a spinal tap or spinal anesthesia
• loss of bladder or bowel control (so you can't control when you go to the bathroom)
• a hard mass or lump at the injection site

If you notice any side effects, talk to your doctor, pharmacist or nurse. This includes possible side effects that are not listed in this instruction. You can also report side effects directly through the yellow card system to:www.mhra.gov.uk/yellow cardor search for MHRA Yellow Card on Google Play or the Apple App Store. By reporting side effects, you can help provide more information about the safety of this medication.

• The active substance is enoxaparin sodium.
• Each mL contains 100 mg of enoxaparin sodium, which corresponds to 10,000 IU of anti-Xa activity.
• Each 3 ml multidose vial contains 30,000 IU (300 mg) of enoxaparin sodium
• The excipients are benzyl alcohol and water for injections.

The Clexane multidose vial contains a clear, colorless to yellowish solution for injection in a glass vial.

It comes in packs of 1, 5 and 10 bottles.

Not all pack sizes can be marketed.

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